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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032967
Receipt No. R000037596
Official scientific title of the study Observational study for PD1 expression status on peripheral CD4 T cells and PDCD1 SNP as markers of Mycobacterium tuberculosis infection susceptibility.
Date of disclosure of the study information 2018/06/13
Last modified on 2018/06/13

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Basic information
Official scientific title of the study Observational study for PD1 expression status on peripheral CD4 T cells and PDCD1 SNP as markers of Mycobacterium tuberculosis infection susceptibility.
Title of the study (Brief title) Observational study for PD1 expression status on peripheral CD4 T cells and PDCD1 SNP as markers of Mycobacterium tuberculosis infection susceptibility.
Region
Japan

Condition
Condition Mycobacterium tuberculosis infection
Classification by specialty
Pneumology Infectious disease Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Evaluation of effects of PD1 and PDCD1 mRNA expression status in peripheral CD4 T cells, and PDCD1 SNP genotypes on anti-tuberculosis chemotherapy and susceptibility to Mycobacterium tuberculosis infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Effects of PD1 and PDCD1 mRNA expression status in peripheral CD4 T cells on anti-tuberculosis chemotherapy.
Key secondary outcomes Effects of PDCD1 SNP genotypes, and PD1 and PDCD1 mRNA expression status in peripheral CD4 T cells on Mycobacterium tuberculosis infection.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Gene
Interventions/Control_1 Blood sampling for PD1 and PDCD1 expression levels and PDCD1 SNP genotyping at clinical routine sampling.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Individuals with Mycobacterium tuberculosis infection who have capability of informed consent
Key exclusion criteria Individuals without capability of informed consent
Target sample size 50

Research contact person
Name of lead principal investigator MASAKI YAMAMOTO
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Address 4-57 Urafune, Minamiku, Yokohama, 2320024, Japan
TEL 0452615656
Email masakiy@yokohama-cu.ac.jp

Public contact
Name of contact person MASAKI YAMAMOTO
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Address 4-57 Urafune, Minamiku, Yokohama, 2320024, Japan
TEL 0452615656
Homepage URL
Email masakiy@yokohama-cu.ac.jp

Sponsor
Institute Respiratory Disease Center, Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Respiratory Disease Center, Yokohama City University Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Respirology, Graduate School of Medicine, Yokohama City University,
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立大学附属市民総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 13 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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